NCT02791282

CTEPH DIAGNOSIS Europe - MRI

CHANGE-MRI (CTEPH DIAGNOSIS Europe - MRI)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,080 (estimated)
• Sponsor: Hannover Medical School · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase III diagnostic trial to demonstrate that functional lung MRI can replace VQ-SPECT in a diagnostic strategy for patients with suspected CTEPH where positive findings are verified with catheter pulmonary angiography (CPA), or computed tomography pulmonary angiography (CTPA)

Detailed description

CHANGE-MRI is a prospective, multicentre, comparative phase III diagnostic study. The study aims to show via an in-place validation that MRI can replace VQ-SPECT as a screening test for chronic pulmonary embolism in the diagnostic algorithm for CTEPH. The diagnostic gold standard is catheter pulmonary angiography (CPA) or computed tomography pulmonary angiography (CTPA) with correction from the clinical outcome after 6-12 months.

Conditions

• Pulmonary Hypertension

Interventions

Type	Name	Description
OTHER	Index test: functional dynamic contrast enhanced (DCE)-MRI	Index test: functional dynamic contrast enhanced (DCE)-MRI Reference test: Ventilation-perfusion (VQ) single-photon emission computed tomography (SPECT) Follow-up per patient: clinical assessment after 6-12 months

Timeline

• Start date: 2016-05-01
• Primary completion: 2020-03-01
• Completion: 2020-06-01
• First posted: 2016-06-06
• Last updated: 2016-06-06

Locations

1 site across 1 country: Germany